510(k) Report

Devices descending from K040992

8 later devices reach 15F X 55CM Excell Split -Tip Catheter, Models 10300606, 10300706 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070572Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR X 28CM…Ash Access Technology, Inc.200773
+2K092597Centros Chronic Hemodialysis Catheter SetAsh Access Technology, Inc.20092—
+2K080400Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure KitAngioDynamics, Inc.200865
+3K141363Centros Long Term Hemodialysis Catheter, Centrosflo Long Term Hemodialysis CatheterMerit Medical Systems, Inc.20141—
+3K101843Duramax Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc.20102Class I
+4K151967Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis CatheterMerit Medical Systems, Inc.20160Class I
+4K131260Nmi Dialysis CatheterNavilyst Medical, Inc.20140Class I
+4K110936Duraflow 2 Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc.201106